context
A pharmaceutical manufacturing site runs hundreds of controlled documents
SOPs, batch records, deviation reports, and the Site Master File split across a DMS, shared drives, and paper. GxP audits are reviewed under strict timelines with direct regulatory consequences, and reporting deadlines are measured in days. The bottleneck is rarely the audit itself: it is the hours of transcription, consolidation, and manual drafting that follow, performed after the team has already left the site and context has begun to fade.
Before
Days of drafting after the audit ends
The auditor finishes the visit with evidence scattered across a phone, a notepad, and an email thread — voice recordings, photographs, and handwritten checklists, none of it linked to the SOPs and batch records held in a separate system. The real work starts afterward: transcribing notes, cross-referencing findings against controlled documents, and assembling the inspection report from a blank Word file. Each report absorbs several hours to days of specialized effort, and because it is written from memory once context has faded, the risk of omissions rises exactly as the submission deadline approaches.
AFTER
Report generated on site, ready to review
The auditor uploads audio notes, photographs, and handwritten checklists directly into a knowledge base configured with the GxP metadata schema, alongside pre-loaded SOPs, batch records, and the Site Master File, all processed and cross-referenced automatically. An agent loaded with a GxP-specific skill assists throughout the audit, retrieving relevant documents on demand and drafting findings as observations accumulate, with each output traceable back to its source evidence. The inspection report is generated from a preconfigured GxP template and exported to Word or PDF before the team leaves the site — ready for expert review rather than written from scratch.
Multi-format KB ingestion
Handwritten checklists, photographs, and scanned documents are processed into a single searchable knowledge base without manual formatting before the audit begins.
Audio transcription with diarization
Field voice notes are transcribed, speaker-segmented, and indexed by topic so specific observations are retrievable by speaker or subject without replaying the full recording.
GxP-configured audit agent
An agent pre-loaded with GxP requirements retrieves relevant documents, surfaces gaps against applicable controls, and drafts findings on demand without switching between systems.
GxP inspection report template
A preconfigured template is populated from accumulated evidence and exported to Word or PDF on the same day, ready for sign-off rather than built from scratch after the visit.
Configurable by domain, not by code
Talk to the AI lab to see how Workbench would apply to your workflow